Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
NCT: NCT07806409 · NOT_YET_RECRUITING
Brief Summary
The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE® SAFESYNC Bioprosthetic Heart Valve, implanted via a transcatheter approach, in patients with severe aortic stenosis, an indication for TAVI, and intermediate or higher surgical risk. The study will enroll 40 participants.
Frequently Asked Questions
What is Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis?
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis is a clinical trial registered under NCT07806409. Current status: NOT_YET_RECRUITING.
What is the status of NCT07806409?
The current status of NCT07806409 (Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis) is: NOT_YET_RECRUITING.
When did Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis start?
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis started on 2026-11.
Related Devices
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.